adenomyosis and ulipristal acetate

Conditions: Adenomyosis

Summary: evaluation of efficiency of selective progesterone receptor modulators (sprm) (ulipristal acetate) on bleeding control and pain for patients with adenomyosis and wish to keep fertility.

after inclusion according to criteria, 2 arms : placebo and ulipristal acetate (ua) 10mg with randomisation, 1 patient with placebo for 3 patients with ua. 48 patients will be included in this trial. the end point will be the bleeding evaluated by pictorial blood-loss assessment chart (pbac) score, the amenorrhea rate and the pain evaluated with visual analogic scale.

Eligibility criteria:
inclusion criteria: * not postmenopausal women aged 30 to 50, * accepting to give consent informed in writing, * suffering from a symptomatic pelvic endometriosis (menorrhagia isolated or associated with pain) * diagnosis information, confirmed the adenomyosis (t2-weighted) mri and/or transvaginal ultrasonography, in the 6 months preceding the inclusion-having a score of bleeding (pbac) \> 100 from j1 to j8 of the menstruation before the visit of inclusion, * with an index of body mass (imc) ≥18 and \< 40, * using a reliable method of non-hormonal contraception (non-hormonal intrauterine device (iuds), sexual abstinence, diaphragm, condoms or vasectomy by the partner, or having undergone a surgical sterilization), * willing and able to complete auto-questionnaires in french * had no difficulties to understand and communicate with the investigator and his representatives * affiliation to a social security or assign. exclusion criteria: * patient with a hormonal oral contraceptive or with a hormonal intrauterine device (iud) contraceptive * patient with a history of surgery (other than a caesarean or a cervical conization) uterus, ablation endometrial or uterine artery embolization, * with other than the endometriosis endometrial pathology, * suffering of myoma of type 0, 1, 2 or 3, * requiring a transfusion or having a ≤6g/dl hemoglobin * existence of systemic coagulation, * history of thromboembolism * progestagen taking severe disorders in the month preceding the tour selection, and corticosteroids and aspirin in the previous week, * existence of pathology renal, respiratory or cardiac severe or progressive, * having a disturbed liver function (defined by the aspartate aminotransferase (asat), alanine amino transferase (alat), γglutamyltranspeptidase, alkaline phosphatase or total bilirubin above 2 times the upper limit of normal), * existence or suspicion of malignancy, * considering pregnancy in the coming year, * pregnant patient or nursing * any clinical condition that the investigator considers incompatible with the conduct of the study in terms of acceptable security, * participation in courses at another clinical study * patient whose accession to the test procedures may be insufficient or for which a long term follow-up seems difficult to achieve * person under authorship or curators under safeguard of justice * history of hypersensitivity to the ulipristal or any of the excipients of esmya ® 5 mg tablet.

Keywords: adenomyosis ulipristal acetate sonography magnetic resonance imaging [mri] pictorial blood-loss assessment chart [pbac]